A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Recruiting
Phase 2
Interventional Study
Metabolic Dysfunction-associated Steatohepatitis (MASH)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 165 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
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About This Trial
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Must be willing to participate in the study and provide written informed consent.
* Male or female, age 18 years or older at the time of signing informed consent
* Body mass Index (BMI) ≥25 kg/m²
* Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoh…
Contacts